Skin LesionsPhase 4NCT01486225
Tolerance Study of the Silicone Bands on Medical Compression Stockings
A Phase 4 study testing Innothera's brand Stockings and Stockings other than Innothera's brand in people with Skin Lesions, run by Laboratoires Innothera at 1 site in France.
Trial summary
The purpose of this study is to identify the nature of skin lesions that develop on contact with the grip-top bands of medical compression stockings, which are composed mainly of silicone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Lesions
- What is being tested?
- Innothera's brand Stockings and Stockings other than Innothera's brand
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2011to Oct 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who notified a health care professional (doctor or pharmacist) of an incident with a grip-top bands compression stocking, regardless of brand and model.
- Subjects presenting skin lesions caused by the contact with silicone-containing grip-top bands of medical compression stockings (all brands combined).
- Subjects for whom the incriminated stockings provide class 2 compression or higher.
- Subjects covered by French national health insurance.
- Subjects who give their written informed consent and who accept the constraints of the study.
Who cannot join
- Known allergy to local anesthetics (lidocaine, etc.).
- History of anaphylactic shock.
- Ongoing antihistamine treatment or having taken during the week before inclusion.
- Patient on ongoing systemic corticosteroids or having taken corticosteroids in the month before inclusion.
- Patient having used a topical corticosteroid in the area where the patch tests or prick tests will be performed during the week before inclusion.
- Phototherapy or sun exposure in the 30 days preceding the skin tests (on the back).
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- Patient having concomitantly used compression stockings and a topical corticosteroid on the thighs in the 48 hours preceding lesion onset.
- List of diseases which will prevent a subject from participating in the study:
- acquired, infectious or drug-induced congenital immunosuppression (systemic corticosteroid therapy, immunosuppressives, chemotherapy),
- Congenital bullous disorder (congenital epidermolysis bullosa) or acquired bullous disorder (pemphigus, pemphigoid, dermatitis herpetiformis, linear IgA dermatosis, etc.).
- Patients with an ongoing or previous history of mental or psychiatric disorder or condition or any other factor interfering with the ability to give informed consent.
- Any major systemic disease making the conduct of the study or the interpretation of the results difficult.
- Patients with ongoing or previous history of decompensated heart failure.
- Chemotherapy or active cancer.
- Pregnancy.
- Patients participating in an ongoing clinical trial or in the exclusion period of a previous trial.
- Persons deprived of their liberty by judicial or administrative decision or persons hospitalized without their consent.
- Legally protected adults under guardianship.
- If the patient accepts the biopsy proposed in the study:
- Patient for whom a skin biopsy is contra-indicated or requiring antibiotic prophylaxis,
- Anticoagulant taken during the 24 hours before inclusion.
- Subject with history of allergy to natural or synthetic latex, chlorhexidine, known healing disorder and/or viral diseases transmissible through the blood documented by the preliminary clinical exam.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploratory Comparative Single-blind Study Evaluating Tolerability of the Silicone Bands on Medical Compression Stockings
The purpose of this study is to identify the nature of skin lesions that develop on contact with the grip-top bands of medical compression stockings, which are composed mainly of silicone.
Read the detailed description
To identify the nature of lesions the investigator will analyse results of the biopsys, microbiological analyses, dermatological tests.
- Conditions
- Skin Lesions
- Being tested
- Innothera's brand Stockings, Stockings other than Innothera's brand
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Innothera's brand StockingsDevice
Also called Medical compression stockings
15 patients having used Innothera branded Stocking
Stockings other than Innothera's brandOther
Also called Other Names:, Medical compression stockings
15 patients having used any other brand than Innothera's brand stockings
| Study group | Role | What they receive |
|---|---|---|
| Innothera's brand Stokings | Other | Innothera's branded grip-top silicone band stokingc Receives: Device: Innothera's brand Stockings |
| Other than Innothera's brand | Other | Not described Receives: Other: Stockings other than Innothera's brand |
What is being measured
The primary outcome is the main question the study is designed to answer.
nature and outcome of skin lesion caused by the silicone from the grip-top band of medical stockings
Patient will be followed during 5 days from the time that lessions occurs
Measured: within 5 days from skin lesion started
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin LesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoires Innothera
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Annick BARBAUD, MD Professor, Principal investigator, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01486225
- Sponsor's protocol ID
- CVE401-10
- Status last verified
- Jul 2012
- First submitted
- 10 Aug 2011
- Last updated
- 8 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Comparative Single-blind Study Evaluating Tolerability of the Silicone Bands on Medical Compression Stockings
- ClinicalTrials.gov ID
- NCT01486225
- Acronym / sponsor ID
- CVE401-10
- Conditions
- Skin Lesions
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Laboratoires InnotheraIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 6 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to identify the nature of skin lesions that develop on contact with the grip-top bands of medical compression stockings, which are composed mainly of silicone.
Detailed description
To identify the nature of lesions the investigator will analyse results of the biopsys, microbiological analyses, dermatological tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Innothera's brand Stokings | Other | Device: Innothera's brand StockingsInnothera's branded grip-top silicone band stokingc |
| Other than Innothera's brand | Other | Other: Stockings other than Innothera's brand |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects who notified a health care professional (doctor or pharmacist) of an incident with a grip-top bands compression stocking, regardless of brand and model.
- Subjects presenting skin lesions caused by the contact with silicone-containing grip-top bands of medical compression stockings (all brands combined).
- Subjects for whom the incriminated stockings provide class 2 compression or higher.
- Subjects covered by French national health insurance.
- Subjects who give their written informed consent and who accept the constraints of the study.
Key exclusion criteria (22 listed)
- Known allergy to local anesthetics (lidocaine, etc.).
- History of anaphylactic shock.
- Ongoing antihistamine treatment or having taken during the week before inclusion.
- Patient on ongoing systemic corticosteroids or having taken corticosteroids in the month before inclusion.
- Patient having used a topical corticosteroid in the area where the patch tests or prick tests will be performed during the week before inclusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Innothera's brand StockingsAlso: Medical compression stockings15 patients having used Innothera branded Stocking | Device | Innothera's brand Stokings |
| Stockings other than Innothera's brandAlso: Other Names:, Medical compression stockings15 patients having used any other brand than Innothera's brand stockings | Other | Other than Innothera's brand |
Primary outcome
nature and outcome of skin lesion caused by the silicone from the grip-top band of medical stockings
Time frame: within 5 days from skin lesion started
Patient will be followed during 5 days from the time that lessions occurs
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annick BARBAUD, MD Professor principal investigator
Central Hospital, Nancy, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Innothera's brand Stockings and Stockings other than Innothera's brand in people with Skin Lesions, run by Laboratoires Innothera at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
nature and outcome of skin lesion caused by the silicone from the grip-top band of medical stockings (time frame: within 5 days from skin lesion started). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2014.